This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Graz, Austria
Unnamed facility
München, Germany
Unnamed facility
Neuss, Germany
Absolute change in mean daily plasma glucose
Time frame: From baseline to day 27
Fasting plasma glucose
Time frame: Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin
Time frame: Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C
Time frame: At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight
Time frame: At baseline, and at planned visits up to week 4
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400mg po bid for 4 weeks
10mg po bid for 4 weeks